510(k) K132085 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
| Applicant | Co-Innovation Biotech Co., Ltd., Guangzhou, Guangdong, CN |
| Decision | Substantially Equivalent, Nov 12, 2013 |
| Received | Jul 5, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132085
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.